GSK Relaunches Blenrep with Myeloma Combo Approval in UK

GSK has achieved a significant milestone with the approval of its drug Blenrep in the United Kingdom. This marks the first regulatory approval for Blenrep following its global withdrawal from the market in 2022. The decision was made by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), allowing Blenrep to be used in combination with other drugs for the treatment of multiple myeloma patients who have undergone at least one prior therapy.

The newly approved use of Blenrep, a BCMA-targeted therapy, involves its combination with either Takeda’s Velcade (bortezomib) or Bristol Myers Squibb’s Pomalyst (pomalidomide), along with dexamethasone, for second-line treatment of multiple myeloma. This approval marks a pivotal moment in GSK’s strategy for Blenrep, aiming for the drug to achieve peak annual sales exceeding 3 billion pounds sterling, approximately $4 billion. Additionally, this global reentry of Blenrep has bolstered GSK's confidence to elevate its 2031 sales goal to over 40 billion pounds, despite some uncertainties surrounding their primary vaccines business.

Blenrep’s current approval helps rehabilitate its standing after a previous withdrawal from the market, which was prompted by disappointing results in a phase 3 trial as a monotherapy for third-line multiple myeloma. As the sole BCMA-targeted antibody-drug conjugate (ADC) therapy, Blenrep has demonstrated its potential, backed by strong phase III data, to enhance survival and remission rates compared to the standard care, potentially transforming treatment approaches at or after the first relapse, according to Hesham Abdullah, M.D., GSK’s global head of oncology R&D.

Despite its earlier history as a monotherapy, Blenrep has demonstrated efficacy in combination therapies. In the DREAMM-7 trial, Blenrep outperformed Johnson & Johnson’s Darzalex when each was paired with Velcade and dexamethasone (Vd). In this trial, the Blenrep-Vd combination reduced the risk of disease progression or death by 59% compared to Darzalex-Vd. Furthermore, the GSK regimen showed a 42% reduction in the risk of death compared to the Darzalex-based combination.

In another trial, DREAMM-8, Blenrep combined with Pomalyst and dexamethasone (Pd) showed a 48% decrease in the risk of disease progression or death compared to the Velcade-Pd combination. Blenrep's combinations are currently undergoing review in 14 other regions worldwide, as stated by GSK. In the United States, the FDA is expected to reach a decision on Blenrep by July 23.

On the global stage, Blenrep will face competition from J&J and Legend Biotech’s CAR-T therapy, Carvykti, although this competition is not yet present in the U.K. Notably, in 2023, J&J halted the rollout of Carvykti in the U.K. due to challenges in meeting global demand with adequate supply.

Blenrep offers an advantage as an off-the-shelf therapy, providing convenience over CAR-T therapy, which involves a complex production process utilizing patients’ own T cells. According to Joseph Mikhael, M.D., from City of Hope and chief medical officer of the International Myeloma Foundation, as patients with multiple myeloma increasingly receive combination therapies at diagnosis, having treatment options with different mechanisms, like Blenrep, is crucial for extending remission and ultimately improving survival rates.